a study of bl-m07d1, bl-m07d1+pertuzumab and bl-m07d1+pertuzumab+docetaxel in patients with unresectable locally advanced or metastatic her2-positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this study is a phase ii clinical trial to evaluate the safety and efficacy of bl-m07d1, bl-m07d1+pertuzumab and bl-m07d1+pertuzumab+docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic her2-positive breast cancer.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age ≥18 years old and ≤75 years old; 4. expected survival time for 3 months or more; 5. patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic her2-positive breast cancer; 6. consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. physical condition score ecog 0 or 1 ; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. no blood transfusion, no colony-stimulating factor, and no albumin are allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements; 12. blood coagulation function: international standardization ratio (inr) 1.5 or less, and the part activated clotting time (aptt) live enzymes acuities were 1.5 x uln; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the end of the dose. female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose. exclusion criteria: 1. received chemotherapy with mitomycin c and nitrosourea within 6 weeks before the first dose, received surgery within 4 weeks before the first dose, and received endocrine therapy within 2 weeks before the first dose; 2. patients with locally advanced or metastatic disease who have received previous systemic therapy; 3. had received prior adc drug therapy with camptothecin derivative as toxin; 4. screening within the first half of the serious heart, cerebrovascular disease; 5. complicated with pulmonary diseases leading to severe impairment of lung function; 6. a history of ild/interstitial pneumonia requiring steroid therapy, current ild/interstitial pneumonia, or suspected ild; 7. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. other primary malignancies diagnosed within 5 years before the first dose; 9. poorly controlled hypertension; 10. patients with active central nervous system metastases; 11. need treatment intervention of unstable thrombotic events, except infusion related thrombosis; 12. patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug; 13. had received more than the following cumulative doses of anthracyclines; 14. systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing; 15. patients with massive or symptomatic effusions or poorly controlled effusions; 16. severe systemic infection within 4 weeks before screening; 17. active autoimmune and inflammatory diseases; 18. human immunodeficiency virus antibody positive, active hepatitis b virus infection or hepatitis c virus infection; 19. previous history of allogeneic stem cell, bone marrow or organ transplantation; 20. a history of severe neurological or psychiatric illness; 21. pregnancy or lactation women; 22. patients who were deemed by the investigator to be ineligible for participation in the study.